IVUS-Guided Treatment for Percutaneous Vascular Interventions (IGT-PVI)

The main objective of the study is to survey and improve the IVUS image quality and X-ray system interoperability by collecting Procedural Data (e.g. raw, pre- processed ultrasound and X-ray data, endpoints such as fluoroscopy time, contrast load and radiation dose, workflow details) during routine intravascular procedures to assure adherence to the high standards of quality during care delivery and promote procedural standardization.

Study Overview

• Status: Suspended
• Conditions: CAD; PAD; DVT
• Intervention / Treatment: Diagnostic test: IVUS Guided

Detailed Description

This is a prospective, multicenter, single-arm study to collect procedural data (e.g., raw, pre-processed IVUS, X-ray, and other procedural data) for image quality, workflow and interoperability assessments. Example of additional procedural endpoint data (e.g., time for fluoroscopy and IVUS, contrast load and radiation dose, workflow details, etc.) will be collected. The study will be conducted in a phased approach.

Since the collection of IVUS raw data with a second non-diagnostic pullback affects procedure time, the two aspects of this study - collection of raw IVUS data and procedural data, will be separated until IVUS raw data can be collected directly from the IVUS system with no additional procedural time.

• Study Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Mesa, Arizona, United States, 85208
      • Southwest Cardiovascular Associates
    • Scottsdale, Arizona, United States, 85251
      • Pulse Cardiovascular
  • California
    • Tarzana, California, United States, 91356
      • Center for Advanced Cardiac and Vascular Interventions
    • Ventura, California, United States, 93003
      • Pacific Cardiovascular and Vein Institute
  • Indiana
    • Munster, Indiana, United States, 46321
      • Community Healthcare System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All comers aged 18 and older scheduled to undergo a percutaneous vascular intervention.

Description

Inclusion Criteria:

1. The Patient is ≥18 years of age.
2. Patient is scheduled to undergo percutaneous vascular intervention - peripheral vascular or coronary PCI procedure.

Exclusion Criteria:

1. Patients not meeting the instructions for use (IFU) of the respective IVUS catheters.
2. Patients with lesions or vessel segments deemed unsafe for multiple IVUS pullbacks.
3. Patients who are pregnant.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
IVUS GUIDED; Those undergoing an already planned IVUS guided treatment for percutaneous vascular interventions	Diagnostic test: IVUS Guided; Those already undergoing an IVUS guided percutaneous vascular intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improve	Analyze IVUS images for improvement using manual and automated visualization	Procedure (one visit)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural IVUS TIME	Procedural time will be recorded. IVUS time of insert and time of removal	Procedure (one visit)
PROCEDURAL RADIATION DOSE	Radiation dose used during procedure will be recorded	Procedure (one visit)
PROCEDURAL AMOUNT OF CONTRAST USED	Amount of contrast used during procedure will be recorded	Procedure (one visit)

Collaborators and Investigators

• Sponsor: Philips Clinical & Medical Affairs Global
• Investigators: Study Chair: Eric Secemsky, MD, Beth Israel Deaconess Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2023
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: December 18, 2023
• First Submitted That Met QC Criteria: January 25, 2024
• First Posted (Actual): February 2, 2024

Study Record Updates

• Last Update Posted (Actual): May 31, 2025
• Last Update Submitted That Met QC Criteria: May 27, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 200421

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No